CARE-Melanoma Trial (CARE-Melanoma)

A Coordinated Approach to Peri-operative Rehabilitation to Enhance Outcomes in Melanoma: the CARE-Melanoma Pilot Randomized Controlled Trial

Melanoma, a serious skin cancer, is increasingly prevalent in Canada. Surgical intervention is essential but poses significant physical and emotional challenges. Rehabilitation is crucial for recovery, helping patients regain strength and confidence while addressing psychological needs. In Ontario, new neoadjuvant chemotherapy regimens are being introduced to improve outcomes by shrinking tumors before surgery. Despite advancements, pre-habilitation and early post-operative rehabilitation services for melanoma patients are currently lacking. This pilot trial aims to evaluate the feasibility and effectiveness of pre- and post-surgery rehabilitation strategies for melanoma patients. The purpose of this pilot trial is to determine the feasibility and preliminary effectiveness of a rehabilitation strategy for individuals with melanoma pre- and post-surgery.

Study Overview

• Status: Not yet recruiting
• Conditions: Melanoma (Skin Cancer)
• Intervention / Treatment: Other: Rehabilitation

Detailed Description

Melanoma, a serious skin cancer, is increasingly prevalent in Canada. Surgical intervention is essential but poses significant physical and emotional challenges. Rehabilitation is crucial for recovery, helping patients regain strength and confidence while addressing psychological needs. In Ontario, new neoadjuvant chemotherapy regimens are being introduced to improve outcomes by shrinking tumors before surgery. Despite advancements, pre-habilitation and early post-operative rehabilitation services for melanoma patients are currently lacking. This pilot trial aims to evaluate the feasibility and effectiveness of pre- and post-surgery rehabilitation strategies for melanoma patients. Participants in this study include individuals with a melanoma diagnosis who are scheduled to receive surgery after a neoadjuvant chemotherapy regime. Eligible potential participants will be referred to the study by their surgical oncologist or oncology care. Participants will be screened for eligibility by a research coordinator. Based on sample size calculations for pilot data, the investigators expect to recruit 30 participants for the study (15 in each group). Participants will be divided into two groups. The first group will include four peri-operative intervention sessions, the total intervention time will be approximately 4 months, with two of the intervention sessions occurring prior to surgery, and two occurring post-surgery. At the pre-surgery sessions participants with receive education on the benefits of exercise pre-treatment, how to exercise safely, and be set up with a tailored exercise routine by a trained physiotherapist. Participants will set goals and action plans to work until their next session. At the post-surgery sessions patients will review their function with the same physiotherapist and again be provided tailored recommendations to maximize their function. The second group will receive usual care.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jenna Smith-Turchyn, PT, PhD; Phone Number: 19058690599; Email: smithjf@mcmaster.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• melanoma diagnosis
• English speaking,
• adults (>18 years of age)
• scheduled to receive surgery after a neoadjuvant chemotherapy regime

Exclusion Criteria:

• <18 years of age
• are not undergoing neo-adjuvant chemotherapy
• self-report any chronic condition, cognitive impairment, or injury that would prevent them from participating independently in moderate intensity exercise

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CARE Intervention Group; This intervention group will include four peri-operative intervention sessions, the total intervention time will be approximately 4 months, with two of the intervention sessions will occur prior to surgery, and two occurring post-surgery. At the pre-surgery sessions individuals with receive education on the benefits of exercise pre-treatment, how to exercise safely, and be set up with a tailored exercise routine by a trained physiotherapist. They will set goals and action plans to work until their next session. At the post-surgery sessions patients will review their function with the same physiotherapist and again be provided tailored recommendations to maximize their function.	Other: Rehabilitation; Includes education on the benefit of exercise and how to exercise safely, rehabilitation to maximize strength, range of motion, and function, set up with a tailored exercise program by a trained physiotherapist or kinesiologist, goal setting and action planning.
No Intervention: Usual Care; This group will receive usual care (no rehabilitation intervention).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention rate	Retention rate is the number of individuals enrolled in the study who complete the intervention.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence rate	Adherence in this project will be assessed by adherence to the rehabilitation session (measured as %).	4 months
Recruitment rate	Recruitment rate is the percentage of eligible individuals approached for the study who enrol in the study.	4 months
Change in overall impairment score	Measured via the Edmonton Symptom Assessment Scale at baseline and 4 month follow-up. Minimum score: 0, Maximum score: 100 - higher scores represent higher levels of overall impairment.	4 months
Change in Physical Activity Level	Measured via the Godin Leisure Time Exercise Questionnaire at baseline and 4 month follow-up. Minimum score: 0, Maximum score: no max - higher scores represent higher levels of physical activity.	4 months
Change in functional mobility	Measured via the 30 second sit to stand at baseline and 4 month follow-up. Minimum score: 0, Maximum score: no max - higher scores represent higher levels of functional mobility.	4 months
Change in functional mobility	Measured via the six minute walk test at baseline and 4 month follow-up. Minimum score: 0, Maximum score: no max - higher scores represent higher levels of functional mobility.	4 months
Change in Grip Strength	Measured via the handheld dynamometer at baseline and 4 month follow-up	4 months
Change in quality of life	Measured via the Functional Assessment of Cancer Therapy (FACT)-Melanoma at baseline and 4 month follow-up. Minimum score: 0, Maximum score: 204 - higher scores represent higher levels of quality of life.	4 months
Change in perception of health status	Measured via the EQ-5D-3L VAS (no extended title) at baseline and 4 month follow-up. Minimum score: 0, Maximum score: 100 - higher scores represent higher perceptions of health status.	4 months
Medication use	Measured via a self-report scale at 4 month follow-up. Minimum score: 0 (no medication used), Maximum score: no maximum - higher scores represent higher use of medications.	4 months
Change in range of motion	Measured via the goniometer at baseline and 4 month follow-up	4 months

Collaborators and Investigators

• Sponsor: McMaster University

Study record dates

Study Major Dates

• Study Start (Estimated): January 20, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: November 24, 2025
• First Submitted That Met QC Criteria: January 5, 2026
• First Posted (Actual): January 6, 2026

Study Record Updates

• Last Update Posted (Actual): January 6, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: rehabilitation; melanoma; pilot trial; peri-operative
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Skin Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Skin Neoplasms; Skin and Connective Tissue Diseases; Melanoma; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Aftercare; Continuity of Patient Care; Rehabilitation
• Other Study ID Numbers: CARE-Melanoma

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No